Inspiratory Muscle Training in Weaning (IMT)

This study has been completed.
Sponsor:
Information provided by:
Euro-American Network of Human Kinetics
ClinicalTrials.gov Identifier:
NCT00922493
First received: June 15, 2009
Last updated: June 17, 2009
Last verified: June 2009
  Purpose

Background: the objective of the present inquiry was to evaluate the weaning process in intubated older people subjected to inspiratory muscle training and to correlate the predictors of ventilatory interruption with its success.

Methods: the patients were divided randomly into an experimental group (EG, n=14; age=82±4 years) that received conventional physiotherapy plus inspiratory muscle training (IMT) with threshold IMT® and a control group (CG, n=14; age=81±6 years) that received only conventional physiotherapy. The predictors evaluates were the maximum inspiratory pressure (MIP) and the index of Tobin (IT). The protocol for muscle training consisted of an initial load of 30% MIP, which was increased by 10% daily; training was administered for five minutes, twice a day, seven times a week with supplemental oxygen for the entire period from the decision to wean up to extubation.


Condition Intervention Phase
Weaning
Other: inspiratory muscle training
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Official Title: Weaning Process in Elderly Intubated Patients Submitted to Inspiratory Muscle Training

Further study details as provided by Euro-American Network of Human Kinetics:

Primary Outcome Measures:
  • Measurement of the MIP

Secondary Outcome Measures:
  • Measurement of rapid shallow breathing (IT)

Study Start Date: December 2007
Study Completion Date: November 2008
Intervention Details:
    Other: inspiratory muscle training

    Protocol of inspiratory muscle training using threshold IMT®: After the MIP was measured, inspiratory muscle training was initiated. The Threshold-IMT® device of a linear pressure load produces a resistance to inspiration through the use of a flow-independent one-way valve. During expiration there is no resistance because the unidirectional valve opens, while during inspiration the valve closes, becoming "hard" due to the resistance of the spring. The suggested protocol was: initial load of 30% of the M24, increasing daily by 10%, with training for five minutes, twice a day, seven times a week in the period from the beginning of the weaning from the MV until the extubation of the patient.

    An essential factor was the use of supplemental oxygen (O2) as needed by the patient. The patients were in DD with fowler 45º.

Detailed Description:

The sample for this investigation was selected in a randomized way in the period between December 2007 and November 2008. The individuals were successively entered in the research as they were admitted to the ICU, in respect of the criteria of inclusion and exclusion. From the total number of admitted patients in the period (n=67), many were excluded because they had been tracheostomized (n=25), were dead (n=13) or were transferred out of the hospital (n=1). Those that remained intubated (n=28) and went to the spontaneous mode were chosen randomly and in alternating fashion were divided into the experimental group (EG) or the control group (CG). The EG (n=14; age=82±4 years-old) underwent conventional physiotherapy plus inspiratory muscular training with threshold IMT® (Respironics/EUA - 2004), and the CG (n=14; age=81±6 years-old) received only conventional physiotherapy with no intervention that favored the inspiratory muscle strengthening.

As inclusion criteria, the individuals of the sample were required to have undergone MV for at least 48 hours in a controlled way13, as intubation is diagnostic for acute respiratory injury type 1 and has a maximum value of MIP of -20 cmH2O16.

Exclusion criteria included any type of acute condition (cardiac arrhythmia) or chronic condition, such as insufficient congestive heart failure or unstable ischemic cardiac disease17, that could compromise weaning or could impede the accomplishment of inspiratory muscle training (neuropathy and myopathy). Tracheostomized patients (in the pre-test), those with neurological problems (cerebral vascular accident, cerebrospinal trauma or spinal medullar trauma), those with morbid obesity or those taking medicine that could cause a disorder of attention, as well as cases of auto-extubation, were also excluded.

The criteria of inclusion and exclusion were evaluated via examination of the patients' medical records and physical examination daily and in each session. The daily adherence of the patients to the necessary parameters for the study was noted for each patient.

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • the individuals of the sample were required to have undergone Mechanical Ventilation for at least 48 hours in a controlled way
  • intubation is diagnostic for acute respiratory injury type 1
  • has a maximum value of MIP of -20 cmH2O16

Exclusion Criteria:

  • any type of acute condition (cardiac arrhythmia) or chronic condition, such as insufficient congestive heart failure or unstable ischemic cardiac disease, that could compromise weaning or could impede the accomplishment of inspiratory muscle training (neuropathy and myopathy).
  • Tracheostomized patients (in the pre-test).
  • patients with neurological problems (cerebral vascular accident, cerebrospinal trauma or spinal medullar trauma.
  • patients with morbid obesity
  • patients taking medicine that could cause a disorder of attention.
  • cases of auto-extubation.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00922493

Locations
Brazil
Quinta D'or Hospital
Rio de Janeiro, Brazil, 22790-140
Sponsors and Collaborators
Euro-American Network of Human Kinetics
  More Information

Additional Information:
No publications provided by Euro-American Network of Human Kinetics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00922493     History of Changes
Other Study ID Numbers: 250525
Study First Received: June 15, 2009
Last Updated: June 17, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Euro-American Network of Human Kinetics:
weaning
inspiratory muscle training
maximum inspiratory pressure (MIP)
index of Tobin (IT)
intubated
intensive care unit
elderly

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014